MAUDE Adverse Event Report: VERATHON INC BLADDERSCAN; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number BVI 9400

Device Problem Failure to Charge (1085)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

Bvi 9400 bladder scanner battery chargers intermittently fail to charge batteries due to an apparent manufacturing problem.This issue is experienced pervasively across our hospital and results in delays in providing care and unnecessary catheterizations for patients who could not receive a bladder scan in a timely manner.Manufacturer response for bladder scanner, bvi 9400 (per site reporter).They deny there is a problem.

• Brand Name: BLADDERSCAN
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON INC; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 11258058
• MDR Text Key: 229618834
• Report Number: 11258058
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BVI 9400
• Device Catalogue Number: U270-0404
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other